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Lexicon Pharmaceuticals has lost its appeal to the FDA of the agency’s complete response letter in March for its investigational add-on type 1 diabetes treatment Zynquista (sotagliflozin). Read More
In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a draft guidance released on Monday.
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The FDA handed out its 25th biosimilar approval to Pfizer’s Humira biosimilar Abrilada (adalimumab-afzb) for treating multiple inflammatory conditions. Read More
Lipocine has received a third complete response letter from the FDA for its novel oral testosterone replacement therapy Tlando for treatment of male hypogonadism. Read More
The FDA has revoked Indivior’s orphan drug designation for its opioid addiction treatment Sublocade (buprenorphine extended-release injection) finding that it was improperly granted. Read More
Recro Pharma announced that the FDA granted its appeal of a complete response letter to an NDA for its intravenous pain medication meloxicam. Read More
Aquestive submitted a citizen petition to the FDA urging the agency to delay approval of Neurelis’ new drug application for its cluster seizure nasal spray Valtoco (diazepam intranasal solution) pending additional clinical studies. Read More
The FDA on Tuesday approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), marking the agency’s 24th biosimilar approval and the third biosimilar of Amgen’s Neulasta. Read More
The drugmaker said it believes that the issues in the complete response letter “can be addressed in a timely manner” to enable the company to resubmit the NDA in the first quarter of 2020. Read More
Biogen has decided to renew its bid for FDA approval in early 2020 of its investigational anti-amyloid Alzheimer’s drug aducanumab after halting clinical trials earlier this year. Read More
Clearside Biomedical received a complete response letter (CRL) from the FDA for its macular edema drug candidate over the need for additional stability data. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) endorsed seven drugs for approval at its October meeting, including a biosimilar of Amgen’s Neulasta (pegfilgrastim). Read More